EIT TLIF Trial

GUDID 04260557775035

Trial, H 9mm, 0°, 32/12

EIT Emerging Implant Technologies GmbH

Spinal implant trial

• Primary Device ID: 04260557775035
• NIH Device Record Key: cad9765e-5025-4f56-9980-8d5fa00a821d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT TLIF Trial
• Version Model Number: TFT00932
• Company DUNS: 313088331
• Company Name: EIT Emerging Implant Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260557775035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170503

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04260557775035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-01-10

On-Brand Devices [EIT TLIF Trial]

• 04260557775547: Trial, H 15mm, 12°, 32/12
• 04260557775530: Trial, H 14mm, L 32mm, W 12mm, 12°
• 04260557775523: Trial, H 13mm, 12°, 32/12
• 04260557775516: Trial, H 12mm, L 32mm, W 12mm, 12°
• 04260557775509: Trial, H 11mm, 12°, 32/12
• 04260557775493: Trial, H 10mm, 12°, 32/12
• 04260557775486: Trial, H 9mm, 12°, 32/12
• 04260557775479: Trial, H 15mm, L 32mm, W 10mm, 12°
• 04260557775462: Trial, H 14mm, L 32mm, W 10mm, 12°
• 04260557775455: Trial, H 13mm, L 32mm, W 10mm, 12°
• 04260557775448: Trial, H 12mm, L 32mm, W 10mm, 12°
• 04260557775431: Trial, H 11mm, L 32mm, W 10mm, 12°
• 04260557775424: Trial, H 10mm, L 32mm, W 10mm, 12°
• 04260557775417: Trial, H 9mm, L 32mm, W 10mm, 12°
• 04260557775400: Trial, H 15mm, L 28mm, W 10mm, 12°
• 04260557775394: Trial, H 14mm, L 28mm, W 10mm, 12°
• 04260557775387: Trial, H 13mm, L 28mm, W 10mm, 12°
• 04260557775370: Trial, H 12mm, L 28mm, W 10mm, 12°
• 04260557775363: Trial, H 11mm, L 28mm, W 10mm, 12°
• 04260557775356: Trial, H 10mm, L 28mm, W 10mm, 12°
• 04260557775349: Trial, H 9mm, L 28mm, W 10mm, 12°
• 04260557775332: Trial, H 15mm, 8°, 32/12
• 04260557775325: Trial, H 14mm, L 32mm, W 12mm, 8°
• 04260557775318: Trial, H 13mm, 8°, 32/12
• 04260557775301: Trial, H 12mm, L 32mm, W 12mm, 8°
• 04260557775295: Trial, H 11mm, 8°, 32/12
• 04260557775288: Trial, H 10mm, 8°, 32/12
• 04260557775271: Trial, H 9mm, 8°, 32/12
• 04260557775264: Trial, H 8mm, 8°, 32/12
• 04260557775257: Trial, H 15mm, L 32mm, W 10mm, 8°
• 04260557775240: Trial, H 14mm, L 32mm, W 10mm, 8°
• 04260557775233: Trial, H 13mm, L 32mm, W 10mm, 8°
• 04260557775226: Trial, H 12mm, L 32mm, W 10mm, 8°
• 04260557775219: Trial, H 11mm, L 32mm, W 10mm, 8°
• 04260557775202: Trial, H 10mm, L 32mm, W 10mm, 8°
• 04260557775196: Trial, H 9mm, L 32mm, W 10mm, 8°
• 04260557775189: Trial, H 8mm, L 32mm, W 10mm, 8°
• 04260557775172: Trial, H 15mm, 8°, 28/10
• 04260557775165: Trial, H 14mm, L 28mm, W 10mm, 8°
• 04260557775158: Trial, H 13mm, 8°, 28/10
• 04260557775141: Trial, H 12mm, L 28mm, W 10mm, 8°
• 04260557775134: Trial, H 11mm, 8°, 28/10
• 04260557775127: Trial, H 10mm, 8°, 28/10
• 04260557775110: Trial, H 9mm, 8°, 28/10
• 04260557775103: Trial, H 8mm, 8°, 28/10
• 04260557775097: Trial, H 15mm, 0°, 32/12
• 04260557775080: Trial, H 14mm, L 32mm, W 12mm, 0°
• 04260557775073: Trial, H 13mm, 0°, 32/12
• 04260557775066: Trial, H 12mm, L 32mm, W 12mm, 0°
• 04260557775059: Trial, H 11mm, 0°, 32/12